FDA Inspection 752879 — Haleon US Holdings LLC
The FDA completed an inspection of Haleon US Holdings LLC on November 2, 2011 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |